HAT in Eye Complications of Behcet's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00001865
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: National Eye Institute (NEI)
• Public title: HAT in Eye Complications of Behcet's Disease
• Scientific title: A Study to Investigate the Safety and Efficacy of HAT to Treat the Ocular Complications Related to Behcet's Disease
• Date of first enrolment: July 1999
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001865
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

Patients must be 18 years of age or older for the primary randomized cohort.

Up to six additional patients under 18 but more than 6 years of age may enroll in a
separate stratum.

Patients has ocular complications of Behcet's disease.

Patients is currently taking a minimum of 15 mg of prednisone, or cyclosporine, or
anti-metabolites, or any combination of these for the treatment of their intraocular
inflammatory disease and retinal vasculitis for at least the past 3 months.

Patients must have had at least two documented ocular attacks due to their Behcet's
disease involving the posterior segment.

Patients has normal renal or liver function or evidence of only mild abnormalities as
defined by the WHO criteria.

Patients has a neutrophil count above 750.

Patients agrees to use acceptable birth control methods throughout the course of the study
and for 6 months after completion of treatment if assigned to Zenapax. If patient is
assigned to placebo and has been unmasked, the patient need not practice birth control.

Patients is able to understand and sign a consent form before entering into the study.
Minor patients will be required to sign an assent.

EXCLUSION CRITERIA:

Patients has received previous treatment with an IL-2 directed monoclonal antibody or any
other investigational agent that would interfere with the ability to evaluate the safety,
efficacy, or pharmacokinetics of Zenapax.

Patients has significant active infection.

Patients has a history of cancer (other than non-melanoma skin cancer) within the past 5
years.

Patient is pregnant or lactating.

Patients with significant symptomatic neurological disease which complicates evaluation of
neurological sequelae of Behcet's disease. This would include multiple sclerosis, stroke,
and other neurodegenerative disease are not eligible. Neuro-Behcet's disease would be
permitted.

In the opinion of the treating physicians the ocular disease is end-stage, and there
would be no reasonable hope for an improvement in visual acuity.

Patient has used Latanoprost within two weeks prior to enrollment, or has a current or
likely need for Latanaprost during the course of the study.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Uveitis

Retinal Disease

Behcet's Syndrome

Intervention(s)

Drug: Daclizumab

Secondary ID(s)

990135

99-EI-0135

Source(s) of Monetary Support

Please refer to primary and secondary sponsors